Risk Class 1 - Patient Lifts Fatalities
The 2002 annual report of one of the European Competent
Authorities stated that during 2001 they received 6 accident
notifications involving patient lifts of which 3 resulted in fatalities.
An inspection at 5 manufacturers found serious absence of
compliance with legal requirements i.e. lack of:
1) risk analysis
2) partial or complete translated user instructions
3) post production review procedures
Three of the five manufacturers did not affix a CE mark and
others required labeling information, nor did they report the placing
on the market to the Competent Authorities.
As a result of the investigation one of the smaller manufacturers
agreed to an immediate recall of all patient lifts (about 350)
delivered during the last 5 years. Another stopped sales for 2
months until all regulatory issues had been complied with.
Since this is a risk class I device, discussions between
Manufacturers and Competent Authorities took place
without Notified Body involvement.
Consequent roundtable discussions between Competent
Authority inspectors and manufacturers revealed that the
three reported fatalities were only the tip of the iceberg.
One manufacturer's own research revealed that annually
thousands of unreported incidents of which dozens resulted
in fatalities were more likely.
A system of color-coding slings differentiating between
light or heavy patient use, lack of maintenance and
personnel training were identified as the most important
causes in this research.
Healthcare professionals object to the use of the word
"deadly" in relation to patient lifts and hastily explain
that daily patient care without the use of patient lifts
is simply unthinkable. It is estimated that in a country
the size of The Netherlands about 40,000 patient
lifts with 80,000 slings are used daily
Institutions consciously choosing only one supplier for
one type of patient lift, supported with regular training
and inspection programs, report good results in prevention
of problems. Almost all agree with the findings about
lack of maintenance, while manufacturers report that only
30% of Institutions sign maintenance agreements when
purchasing patient lifts.
Competent Authority inspectors announced that during 2003
they will continue to focus on regulatory compliance by the
risk class I device manufacturers and the safe use, maintenance
and training of personnel when visiting patient care institutions.
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